Randomized clinical trial comparing the efficacy and safety of oxfendazole at 20 mg/kg per dose in one and two dose regimens with a two-dose regimen of triclabendazole at 10 mg/kg in an endemic region of the highlands of Peru. Adults with fascioliasis in rural communities will be screened for inclusion and exclusion criteria and a total of 336 subjects (112 per study arm) with chronic Fasciola infection will be enrolled and assigned randomly to the study arms in a 1:1:1 ratio. The primary efficacy (cure and egg reduction) endpoints will be assessed on day 7 and 30 post treatment. The secondary safety endpoint visits will be performed in days 0, 3, 7 and 30 post-treatment and Population Pharmacokinetics (PK) modeling studies will be performed in the first 24 hours after the first dose of oxfendazole.
Male and female subjects eighteen years or older with positive stool microscopy and/or egg counts confirmed by qualitative and/or quantitative stool microscopy performed within the past 14 days.
Subjects capable of understanding the informed consent process and providing written informed consent.
Willingness to give informed consent.
Subjects reporting previous treatment for fascioliasis
Subjects with a stool egg count > 300 eggs/g in stool samples
Women with a positive urine pregnancy test or planning to become pregnant
Women that are nursing
Universidad Peruana Cayetano Heredia
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Oxfendazole Development Group
Collaborator